PlainRecordsFDA · Drug recall
Doxycycline Capsules… and 1 more product
- Date
- March 25, 2020
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries, Inc.
- Reason
- CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
- Distribution pattern
- Nationwide in the USA
2 products in this recall
Doxycycline Capsules…
- Product
- Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.
- Quantity
- 624 bottles
- Codes and lots
- Lot #: AA39490, Exp 03/2021
- Recall started
- March 13, 2020
- Recall number
- D-1032-2020
Doxycycline Capsules…
- Product
- Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50.
- Quantity
- 172,320 bottles
- Codes and lots
- Lot #: 3983720, Exp 10/2020; 3990461, 3990464, 3990465, 3990466, 3990470, Exp 11/2020; AA42499, AA42510, AA44468, AA44470, Exp 04/2021; AA55073, AA55074, AA55075, Exp 05/2021; AA61486, Exp 06/2021
- Recall started
- March 13, 2020
- Recall number
- D-1033-2020
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-1032-2020, D-1033-2020. The agency record governs; check it and the company before acting.